A Comparison Between Two Post-operative Dressings in the Treatment of Surgical Incisions in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- A comparison of wear time between the two post-operative dressings under study.
研究概览
简要总结
Surgical site infections are one of the leading causes of post-operative morbidity and mortality worldwide. The ideal post-operative dressing is impermeable and remains intact preventing contamination of the incision with microorganisms. In addition, it is often difficult for the patient to identify breaks in dressing integrity. This trial compares a post-operative dressing (DrySee® Inc. Houston Tx) with moisture detection allowing the patient to recognize when the dressing is compromised to a standard post-operative dressing (Tegaderm® + Pad, 3M, St. Paul, MN). The ideal dressing also allows the patient to shower without removing the dressing.
详细描述
Healthy subjects drawn from the general population. will undergo a 1.5cm incision on the volar forearm of each arm. The incision will be closed with streriostrips. The subject's incisions will then be randomized to receive either a Tegaderm® + Pad transparent film dressing or DrySee® dressing with moisture detection. The incisions will be photographed three times per week. Data on dressing wear time, integrity and adverse events will be collected every two days in the clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years old.
- •Subject has read, understood, and signed approved consent, and is willing to participate and comply with the study procedures and requirements.
排除标准
- •Subject on an investigational drug or therapeutic device within 30 days of the study visit.
- •Presence of a condition that PI considers will compromise the subject's ability to participate in the study.
- •Known allergy to any of the dressings or their components.
- •The subject has a history of excessive bleeding.
- •The subject has a history of keloid formation.
结局指标
主要结局
A comparison of wear time between the two post-operative dressings under study.
时间窗: 6-weeks
A comparison of wear time between the two post-operative dressings under study.
次要结局
- A comparison of dressing integrity between the two dressings under study if the dressings remains intact at the treatment visits by visual assessment.(6-weeks)
- A comparison of adverse events between the two treatment arms.(6-weeks)
- The effectiveness of liquid indication in identifying dressing compromise by visual assessment(6-weeks)
- A comparison between the two dressings to maintain waterproof protection of the incision by visual assessment if there was a break in the dressing border.(6-weeks)